Anterior cruciate ligament reconstruction with autologous semitendinosus- or quadriceps tendon graft: Are there differences in objective and subjective patients' outcome? A randomized controlled trial.

Not Applicable

Conditions: Anterior Cruciate Ligament Rupture
M23.51
S83.51

Registration Number: DRKS00010246

Lead Sponsor: niversitätsklinikum Münster

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

Primary rupture of anterior cruciate ligament (for randomization)
- for the accessory controll group (study arm No 3, ACL Revision with Quadriceps tendon graft) a rerupture after primary ACL reconstruction/suture is inclusion criterion
- Age 16-60 years
- Signed informed consent, study and privacy agreements
- Succesfully completed all standard preoperative procedures especially from anaesthesological und surgical point of view
- Willing to participate on follow-up examinations.
- Minor concomitant injuries such as small meniscus lesions (<1/3 partial meniscectomy or minor sutures), I-II° MCL instability, bone bruise without relevant chondral lesions or hemarthros are acceptable for inclusion.

Exclusion Criteria

- No compliance
- Denial of participating in rehabilitation program
- Severe traumatic or degenerative chondral or meniscal injuries
- Multiligamental injuries/instability of higher grades (LCL, PCL or III° MCL)
- Prior donation/extraction of tendon grafts at the same leg (except for the study arm No 3 / ACL Revision group if quadriceps tendon is still available)
- Relevant co-medication or co-morbidities
- Pregnancy

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Instrumented Lachman Test side-by-side (delta in mm), measured by Rolimeter(R) determined after 12 months (3. FU).<br><br>Further examination intervals: pre-/intraoperative, 1st FU 6 weeks (clin. scores and range of motion only), 2nd FU 3-6 months, 24 months, optional 5 and 10 years.

Secondary Outcome Measures

Name	Time	Method
functional Scores (Lysholm, IKDC, Tegner, pain scale) evaluated with an iPad based Heartbeat ONE Device, Back-in-Action Analyses, Isokinetic msucle strength measurments, walking analyses, rang of motion, Pivot Shift Test; determined after 12 months.<br><br>Further examination intervals: pre-/intraoperative, 1st FU 6 weeks (clin. scores and range of motion only), 2nd FU 3-6 months, 24 months, optional 5 and 10 years.